BPHNCT02876757
5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression
An observational study of BPH and Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
In December 2015, Health Canada issued a warning about a potential relationship between suicide and finasteride use and called for further research. No population based studies have assessed the risk of suicide with finasteride use, and this risk is not currently part of the product monograph. Read more about this study
- Who is it for?
- Ages 66 to 120 years, men only
- Conditions the study is for
- BPH, Depression, Suicide
- What is being tested?
- 5ARI
- How many people
- 186,394 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Mar 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 to 120 years
- Men only
- No healthy volunteers
- Older adult
Study population: All men >66 years of age in Ontario between 2003-2013
Who may be able to join
- All men >66 years of age in Ontario between 2003-2013
Who cannot join
- Non Ontario residents
- No prescriptions filled in prior 180 days
- Prior exposure to finasteride/dutasteride in the 2 years prior to study enrollment.
- Prescription initiated during hospital admission or ER visit.
About this study
In December 2015, Health Canada issued a warning about a potential relationship between suicide and finasteride use and called for further research. No population based studies have assessed the risk of suicide with finasteride use, and this risk is not currently part of the product monograph. Furthermore, the link between depression and finasteride has not been well studied in the older population who are the primary users of this medication.
- Conditions
- BPH, Depression, Suicide
- Being tested
- 5ARI
- Medical subject headings
- Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5ARIDrug
Exposure to finasteride/dutasteride
| Study group | Role | What they receive |
|---|---|---|
| 5ARI Users | Not described Receives: Drug: 5ARI | |
| Non 5ARI users | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database)
- Ontario Registrar General Death database. Use the COD_primary variable (used from 2003 onwards) to define suicide, based on an ICD10 code of X60-X84.
- NACRS: X60-84 (dx10code1-dx10code10) AND dead on arrival or death after arrival (visdisp2002 = 10 or 11). Consider admission date the date of the event.
- OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event.
- CIHI-DAD (Consider admission date the date of the event):
- suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp="07".
Measured: Through study completition, an average of 18 months.
Secondary outcomes (2)
Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)
- NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm).
- OMHRS: admission with suicide ideation.
- Self injury attempts: D1A or selfinjury_attempt=3, 4, 5, or 6 ii. Self injury intent: D1B or selfinjury_intent=1 iii. Self injury considered: D1C or selfinjury_cons=3, 4, 5 or 6 iv. Self injury plan: D1DB or suicide_plan=1
Measured: Through study completition, an average of 18 months.
Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)
- Any CIHI-DAD/SDS ICD 10 code, OR
- Any OMRHS code Axis1_dsm4code1-19 or Axis2_dsm4code 1-7 OR
- Look for any OHIP record billed by Mainspecialty = "PSYCHIATRY" with a diagnosis of depression OHIP dxcode 311, OR
- ≥2 GP visits within 2 years AND both with OHIP dxcode 311
- OHIP dxcode: 311 ii. ICD 10: F32.0, F32.1, F32.2, F32.3, F32.8, F32.9, F33.0, F33.1, F33.2, F33.3, F33.4, F33.8, F34.1 iii. Psychiatry visits defined as any of these OHIP fee codes: A195, A895, A190, A795, A695, A395, A196, A193, A194, A191, A192 iv. OMHRS: 29620-29626, 29630-29636, 31100 (major depressive disorder)
Measured: Through study completition, an average of 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJan 2003
- Primary completionDec 2013
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BPHStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 186,394 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876757
- Sponsor's protocol ID
- 2016 0906 192 000
- Status last verified
- Jan 2024
- First submitted
- 5 Aug 2016
- Last updated
- 12 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression
- ClinicalTrials.gov ID
- NCT02876757
- Acronym / sponsor ID
- 2016 0906 192 000
- Conditions
- BPH, Depression, Suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186,394 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Posted 5 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In December 2015, Health Canada issued a warning about a potential relationship between suicide and finasteride use and called for further research. No population based studies have assessed the risk of suicide with finasteride use, and this risk is not currently part of the product monograph. Furthermore, the link between depression and finasteride has not been well studied in the older population who are the primary users of this medication.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5ARI Users | – | Drug: 5ARI |
| Non 5ARI users | – | – |
Who may qualify
- Ages
- 66 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All men >66 years of age in Ontario between 2003-2013
Key inclusion criteria (1 listed)
- All men >66 years of age in Ontario between 2003-2013
Key exclusion criteria (4 listed)
- Non Ontario residents
- No prescriptions filled in prior 180 days
- Prior exposure to finasteride/dutasteride in the 2 years prior to study enrollment.
- Prescription initiated during hospital admission or ER visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5ARIExposure to finasteride/dutasteride | Drug | 5ARI Users |
Primary outcome
Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database)
Time frame: Through study completition, an average of 18 months.
1. Ontario Registrar General Death database. Use the COD_primary variable (used from 2003 onwards) to define suicide, based on an ICD10 code of X60-X84. 2. NACRS: X60-84 (dx10code1-dx10code10) AND dead on arrival or death after arrival (visdisp2002 = 10 or 11). Consider admission date the date of the event. 3. OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event. 4. CIHI-DAD (Consider admission date the date of the event): i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp="07".
2 secondary outcomes
Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)
Time frame: Through study completition, an average of 18 months.
Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)
Time frame: Through study completition, an average of 18 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of BPH and Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database) (time frame: Through study completition, an average of 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.